First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial
Language English Country Netherlands Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial
PubMed
29404806
DOI
10.1007/s10549-017-4658-x
PII: 10.1007/s10549-017-4658-x
Knihovny.cz E-resources
- Keywords
- Advanced breast cancer, CDK4/6, MONALEESA-2, Ribociclib,
- MeSH
- Aminopyridines administration & dosage MeSH
- Adult MeSH
- Kaplan-Meier Estimate MeSH
- Quality of Life MeSH
- Letrozole administration & dosage MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Metastasis MeSH
- Young Adult MeSH
- Biomarkers, Tumor MeSH
- Breast Neoplasms drug therapy metabolism pathology MeSH
- Antineoplastic Combined Chemotherapy Protocols adverse effects therapeutic use MeSH
- Purines administration & dosage MeSH
- Receptor, ErbB-2 metabolism MeSH
- Receptors, Estrogen metabolism MeSH
- Receptors, Progesterone metabolism MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Neoplasm Staging MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Aminopyridines MeSH
- Letrozole MeSH
- Biomarkers, Tumor MeSH
- Purines MeSH
- Receptor, ErbB-2 MeSH
- Receptors, Estrogen MeSH
- Receptors, Progesterone MeSH
- ribociclib MeSH Browser
PURPOSE: The phase 3 MONALEESA-2 study demonstrated that addition of ribociclib (RIB) to letrozole (LET) significantly improved progression-free survival (PFS) in patients (pts) with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC). Here, we evaluated duration of response (DoR), tumor shrinkage, PFS by treatment-free interval (TFI), and health-related quality of life (HRQoL). METHODS: Postmenopausal women (N = 668) with HR+ , HER2- ABC and no prior systemic therapy for ABC were randomized to RIB (600 mg/day; 3 weeks on/1 week off) plus LET (2.5 mg/day; continuous) or placebo (PBO) plus LET. Primary end point was PFS; HRQoL was the secondary end point; DoR was exploratory end point and PFS by TFI was post hoc analysis. RESULTS: Of 501 pts with measurable disease and confirmed complete or partial response, median DoR was 26.7 months (95% CI, 24.0-NR) in the RIB arm versus 18.6 months (95% CI, 14.8-23.1) in the PBO arm. At 8 weeks, more pts in the RIB arm (32%) versus the PBO arm (17%) experienced best percentage change ≥ 60%. The average pain reduction was greater in the RIB arm (26%) versus the PBO arm (15%). PFS benefit was seen with RIB vs PBO, irrespective of TFI. CONCLUSION: RIB plus LET versus PBO plus LET is associated with earlier and more durable tumor response, greater degree of tumor shrinkage and pain reduction, and PFS benefit irrespective of TFI. These data further support RIB plus LET as a first-line treatment option for postmenopausal women with HR+ , HER2- ABC.
Centre Léon Bérard Lyon France
Centre René Gauducheau Institut de Cancérologie de l'Ouest Saint Herblain France
Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic
Highlands Oncology Group Fayetteville AR USA
Hospital Clínico Universitario e Instituto de Investigación Santiago CIBERONC A Coruña Spain
Hospital Universitario La Paz Madrid Spain
Hospital Universitario Virgen de la Victoria IBIMA Málaga Spain
Institut Català d'Oncologia IDIBELL L'Hospitalet de Llobregat Barcelona Spain
Minnesota Oncology Minneapolis MN USA
Novartis Pharmaceuticals Corporation East Hanover NJ USA
Oncology Hematology Associates of Southwest Virginia Roanoke VA USA
Oncology Hematology Care Kenwood OH USA
Perlmutter Cancer Center at New York University Langone Health New York NY USA
Rocky Mountain Cancer Centers Aurora CO USA
Saint Luke's Health System Kansas City MO USA
References provided by Crossref.org
ClinicalTrials.gov
NCT01958021
